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A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer’s Disease


Brief Summary:

The purpose of this study is to assess the safety, tolerability, biomarker and cognitive
efficacy of investigational products in subjects who are known to have an Alzheimer’s
disease-causing mutation by determining if treatment with the study drug slows the rate of
progression of cognitive impairment and improves disease-related biomarkers.

This is an analysis study for an MPRP: DIAN-TU-001 Master NCT01760005


Inclusion Criteria:

– Between 18-80 years of age

– Individuals who know they have an Alzheimer’s disease-causing mutation or are unaware
of their genetic status and have dominantly inherited Alzheimer’s disease (DIAD)
mutation in their family.

– Are within -15 to + 10 years of the predicted or actual age of cognitive symptom

– Cognitively normal or with mild cognitive impairment or mild dementia, Clinical
Dementia Rating (CDR) of 0-1 (inclusive)

– Fluency in DIAN-TU trial approved language and evidence of adequate premorbid
intellectual functioning

– Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron
Emission Tomography (PET), and complete all study related testing and evaluations.

– For women of childbearing potential, if partner is not sterilized, subject must agree
to use effective contraceptive measures (hormonal contraception, intra-uterine device,
sexual abstinence, barrier method with spermicide).

– Adequate visual and auditory abilities to perform all aspects of the cognitive and
functional assessments.

– Has a Study Partner who in the investigator’s judgment is able to provide accurate
information as to the subject’s cognitive and functional abilities, who agrees to
provide information at the study visits which require informant input for scale

Exclusion Criteria:

– History or presence of brain MRI scans indicative of any other significant abnormality

– Alcohol or drug dependence currently or within the past 1 year

– Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or
foreign metal objects in the eyes, skin or body which would preclude MRI scan.

– History or presence of clinically significant cardiovascular disease, hepatic/renal
disorders, infectious disease or immune disorder, or metabolic/endocrine disorders

– Anticoagulants except low dose (≤ 325 mg) aspirin.

– Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the
past six months.

– History of cancer within the last 5 years, except basal cell carcinoma, non-squamous
skin carcinoma, prostate cancer or carcinoma in situ with no significant progression
over the past 2 years.

– Positive urine or serum pregnancy test or plans or desires to become pregnant during
the course of the trial.

– Subjects unable to complete all study related testing, including implanted metal that
cannot be removed for MRI scanning, required anticoagulation and pregnancy.


  • University of California San Diego Medical Center, La Jolla, California, United States, 92037
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